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FDA 510(k)

NEBULIZER (DIRECT PATIENT INTERFACE)

K-Number: K915075 · 1992-07-16

ApplicantMedi Nuclear Corp., Inc.
Decision Date1992-07-16
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEBULIZER (DIRECT PATIENT INTERFACE) is the device name listed in this FDA 510(k) record. The listed applicant is Medi Nuclear Corp., Inc.. It received FDA 510(k) clearance on 1992-07-16 under 510(k) number K915075. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEBULIZER (DIRECT PATIENT INTERFACE)?

NEBULIZER (DIRECT PATIENT INTERFACE) is a medical device that received FDA 510(k) clearance on 1992-07-16. The listed applicant is Medi Nuclear Corp., Inc.. The 510(k) number is K915075.

When did NEBULIZER (DIRECT PATIENT INTERFACE) receive FDA 510(k) clearance?

NEBULIZER (DIRECT PATIENT INTERFACE) received FDA 510(k) clearance on 1992-07-16, under 510(k) number K915075.

Who is the listed applicant for NEBULIZER (DIRECT PATIENT INTERFACE)?

The FDA 510(k) record lists Medi Nuclear Corp., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEBULIZER (DIRECT PATIENT INTERFACE)?

The FDA product code for NEBULIZER (DIRECT PATIENT INTERFACE) is CAF.

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Other records listing Medi Nuclear Corp., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K082541HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEMK080969HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510K080657NEB-90 LARGE VOLUME MEDICATION NEBULIZERK865107AERO-VENT AEROSOL UNITK865093SAFE-T-SHIELD MOUTHPIECEK863996MODEL XE-103 XENON/MASTER II

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Related Devices (Code: CAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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